Development and Validation of Analytical Methods for Lacosamide

Lacosamide is an anti epileptic drug, for which, two simple, sensitive, accurate, precise, and economical methods (method 1 and 2) have been developed for the quantitative estimation of Lacosamide in bulk and pharmaceutical formulation. Method-1 is a simple, accurate and sensitive HPLC method and the chromatographic separation was carried out on C₈ column Welchrom (250 × 4.6mm, 5μ.) using a mobile phase composition of potassium dihydrogen phosphate buffer: acetonitrile (850:150 v/v) pumped at flow rate of 1.5 ml/min. The eluent was monitored at 215 nm with a diode array detector. Method-2 was based on condensation reaction between Lacosamide and vanillin in presence of conc. Sulphuric acid involving the formation of violet colored chromogen which showed linearity in the range 100–500μg/ml at a λmax of 613 nm. The methods were statistically validated for precision, accuracy, robustness and recovery as per ICH guidelines